Multiple Sclerosis Drugs Market Regulations and Competitive Landscape Outlook to 2020

Multiple sclerosis (MS) is known as one of the major autoimmune disorders of CNS (Central Nervous System) that attacks myelin in the CNS particularly the optic nerves and spinal cord, which is largely composed of myelin. In MS progressive deterioration of the myelin leaves a scar (sclerosis) in multiple areas of the brain, leading to the plaques and lesions formation around. Primary symptoms of MS include tingling and numbness, thinking problem, muscle weakness, prickling sensations, problems with balance, mobility and visual disturbances. Several other symptoms that progress over time include mood swing, speech problem and trigeminal pain. Each case of MS is presented differently, since some patients may show presence or absence of typical symptoms along with ranging severity of symptoms. Onset of MS peaks between 21 and 40 years; women are affected more frequently than males (2-3 times as many women than men affected).

Approximately 3-3.5 million people in the world have multiple sclerosis. MS is 5-6 times more prevalent in temperate climate than in tropical climates. Around 350,000 to 500,000 people in the United States alone have MS and around 75,000 people are suffering from MS in the United Kingdom. As there is no well defined cure for MS, treatment is aimed to improve quality of life of patients. However, based on the condition of the disease the treatment for MS can be considered for treatment for relapses of MS symptoms (steroids), treatment for particular MS symptoms and treatment to slow the progression of disease (disease-modifying medicines).

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Corticosteroids such as prednisone, methylprednisolone and Interferon-beta1a or beta 1 b and glatiramer acetate are most commonly used for the treatment of MS. There are approximately eight late stage Copaxone (glatiramer acetate injection) from Teva Pharmaceuticals Industries Ltd. is the most widely used drug for treatment of MS patients with a sales of around US $ 4.6 billion in the year 2012 followed by Avonex (interferon beta-1a) from Biogen Idec and Rebif (interferon beta-1a) from EMD Serono/ Pfizer. According to the Therapeutics and Technology Assessment Subcommittee of the American Academy of Neurology and the MS Council for Clinical Practice Guidelines it is appropriate to consider interferon beta (IFNβ) for treatment in any patient who is at high risk for developing clinically definite MS, or who already has either RRMS or SPMS with relapses.

US FDA has recently approved a drug Tecfidera (dimethyl fumarate) from Biogen Idec, for the treatment of relapsing forms of MS and relapsing-remitting multiple sclerosis (RRMS), which is known to be the most common form of MS. Gilenya (fingolimod) from Novartis is projected to be a blockbuster seller, with estimates putting it in the top 10 drugs by the year 2018 and it is expected to reach close to US $5.4 billion in sales. In 2014, FDA also approved Lemtrada by Sanofi/Genzyme and Plegridy by Biogen Idec. North America and Europe are the major territories identified with maximum MS patients, making them key share holders in the total MS treatment drugs market. Few of the top leading manufacturing companies of MS drugs are Biogen Idec., Novartis, Sanofi Aventis, and Teva Pharmaceuticals, etc.

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